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Recruiting NCT07224191

Hippocampal Oscillations During Exploration

No phase Interventional Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Visual Exploration, Ambulatory Exploration.
Who it may be relevant to
Registry conditions: Epilepsy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Human Hippocampal Oscillations During Visuomotor Exploration

Overview

The objective of this study is to determine how visuomotor exploration relates to hippocampal activity along its long axis. The study will investigate the neurophysiological mechanisms in the hippocampus during (1) visual exploration in surgical patients using high-resolution iEEG, and (2) ambulatory exploration in patients implanted with RNS devices.

Detailed description

Aim 1 - Visual Exploration in Surgical Patients Investigators will study 20 surgical patients with high-resolution intracranial EEG (iEEG) to investigate hippocampal activity during visual exploration. Participants will view between 10-15 panoramic environments using Meta Quest AR/VR glasses while their eye movements and head turns are tracked. Eye-tracking, head-turn, and iEEG data will be synchronized with visual stimuli, and intracranial EEG and single-unit data will be analyzed for changes in neuronal firing and brain activity before and after saccades.

Aim 2 - Ambulatory Exploration in RNS Patients and Healthy Controls Investigators will study 12 epilepsy patients with implanted responsive neurostimulator (RNS) devices and 24 healthy controls (HCs) during real-world exploration. Participants will walk through and explore visually distinct rooms while wearing synchronized high-density EEG (hdEEG), eye-tracking glasses, and body position sensors. Data from hippocampal iEEG, hdEEG, eye tracking, and motion sensors will be synchronized offline to examine brain-behavior relationships and the influence of cognitive load on saccade-hippocampal interactions.

Interventions

  • Other Visual Exploration
    Cognitive testing while admitted to the epilepsy monitoring unit (number of sessions will vary depending on patient availability and stamina).
  • Other Ambulatory Exploration
    Series of cognitive tasks completed during a study visit.

Primary outcome measures

  • Hippocampal Theta Power Under High Cognitive Loads [Time frame: Study Visit (Day 1)]
  • Hippocampal Theta Power Under Medium Cognitive Loads [Time frame: Study Visit (Day 1)]
  • Hippocampal Theta Power Under Low Cognitive Loads [Time frame: Study Visit (Day 1)]
  • Hippocampal Theta Power Under No Cognitive Loads [Time frame: Study Visit (Day 1)]
  • Coherence Time-Locked to the Saccade Under High Cognitive Loads [Time frame: Study Visit (Day 1)]
  • Coherence Time-Locked to the Saccade Under Medium Cognitive Loads [Time frame: Study Visit (Day 1)]
  • Coherence Time-Locked to the Saccade Under Low Cognitive Loads [Time frame: Study Visit (Day 1)]
  • Coherence Time-Locked to the Saccade Under No Cognitive Loads [Time frame: Study Visit (Day 1)]

Eligibility criteria

Inclusion criteria

All subjects:

  • Adults (18-70 years)
  • Able to provide informed consent

Aim 1: Surgical epilepsy patients' inclusion criteria

  • Implanted hippocampal depth electrodes for Stage 1 epilepsy surgery
  • MMSE>=24

Aim 2: RNS patients Inclusion criteria

  • Implanted RNS device with at least one hippocampal depth electrode
  • At least 5 months post-implantation to avoid the post-implant effect
  • Have a relatively low number of seizures, defined as <1 generalized tonic-clonic or other seizure with potential to fall or cause injury per month
  • Able to walk and wear research equipment without assistance
  • MMSE>=24

Aim 2: Healthy Control Inclusion criteria • Able to walk and wear research equipment without assistance

Exclusion criteria

RNS patients, Aim 2:

  • Any generalized tonic-clonic seizure within the last week

All subjects:

  • Legally blind
  • Smoking tobacco, marijuana, recreational drugs or alcohol use within 1 week of cognitive testing
  • Unable to give informed consent
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07224191 · 25-01119 · R61DC022830-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗